A Good One on Drug Trials

Big Pharma

Barry Meier, one The Audit’s favorites, has an excellent piece on today’s New York Times business cover about a debate over whether pharmaceutical companies should publicly disclose the results of all clinical drug trials, not just positive ones.

If you don’t follow Big Pharma, and I don’t, it’s an interesting window onto a business subculture.

The top of the story describes how GlaxoSmithKline agreed to disclose results of trials for Paxil and other drugs as part of a settlement with New York State. A doctor at the Cleveland Clinic came across data about a diabetes drug called Avandia.

The story says: “He and a colleague quickly analyzed the data, and on Monday, The New England Journal of Medicine released its finding that Avandia posed a heightened cardiac risk.”

Here’s a key paragraph.

Dr. Ronald L. Krall, chief medical officer for Glaxo, said his company sharply disputed the methodology of (the Cleveland doctor’s) study, and a top F.D.A. official said that the agency had previously informed doctors about Avandia‚Äôs heart risks.

In other words, the Cleveland doctor was right. One more line on this:

Some experts also believe that releasing the results of hundreds of studies involving drugs or medical devices might create confusion and anxiety for patients who are typically not well prepared to understand the studies or to put them in context.

That’s not much of an argument for non-disclosure of bad news.

Great job, Barry.

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Dean Starkman Dean Starkman runs The Audit, CJR's business section, and is the author of The Watchdog That Didn't Bark: The Financial Crisis and the Disappearance of Investigative Journalism (Columbia University Press, January 2014). Follow Dean on Twitter: @deanstarkman.